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NCT04751045 · ClinicalTrials.gov registry record · NA
Comparison and Outcomes of Endoscopic Ultrasound Liver Biopsies Versus Percutaneous Liver Biopsies
A NA study, sponsored by University of Missouri-Columbia.
- Completed
- Registry status
- NA
- Development phase
- 78
- Enrollment target
NCT04751045 is a NA study that has completed, run by University of Missouri-Columbia. The registered enrollment target is 78 participants.
The verdict
NCT04751045, a NA study, has completed, sponsored by University of Missouri-Columbia.
- COMPLETED
- Registry status
- NA
- Development phase
- 78 participants
- Enrollment target
Study Summary
Histopathological examination of liver tissue is used to determine the etiology and extent of liver disease. In order for a clinician to make a better-informed decision regarding a patient with liver disease, the liver biopsy specimen has to be adequate and of high quality for pathological interpretation. It is generally agreed that an adequate liver biopsy has to have ≥6-12 intact portal tracts for pathological review and interpretation.(1) Historically, three approaches have been used to obtain a liver biopsy: percutaneous, transjugular (TJ-LB) and laparoscopic approach (LA-LB)- with percutaneous liver biopsy (P-LB) being the most commonly employed. Endoscopic ultrasound-guided liver biopsy (EUS-LB), a newer approach, is now being performed by select skilled endoscopists across the country. EUS-LB is advantageous over existing techniques because it enables visualization and avoidance of vessels that are 1mm in diameter, provides access to both lobes of the liver and theoretically is less painful due to avoiding somatic pain fibers. Further, in patients that are already undergoing esophagogastroduodenoscopy, EUS-LB can be performed simultaneously and spare the patient an additional procedure. Because of the plausibility of reduced pain, number of procedures and possibly complications, EUS-LB may be cost-effective over existing methods. There is limited data evaluating the safety and efficacy of EUS-LB versus percutaneous liver biopsy. The investigators hope to provide answers in a prospective study comparing between patients, who are already undergoing liver biopsy, randomly assigned to either EUS-LB or P-LB. The investigators will compare outcomes such as pain, bleeding, hospitalization, and tissue diagnosis between the two groups. This will allow us to add to the existing data for the use of EUS-LB. If patients are found to have less adverse events and better outcomes using EUS-LB versus percutaneous-LB this may become the preferred method of diagnosis in this p
Interventions
- PROCEDURE EUS liver biopsy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2020-10-25 |
| Est. Completion | 2021-10-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04751045
The ClinicalTrials.gov registry entry for NCT04751045 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Missouri-Columbia, which has 291 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which EUS liver biopsy is the first listed.
NCT04751045 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04751045 about?
NCT04751045 is a clinical study titled "Comparison and Outcomes of Endoscopic Ultrasound Liver Biopsies Versus Percutaneous Liver Biopsies". Histopathological examination of liver tissue is used to determine the etiology and extent of liver disease. In order for a clinician to make a better-informed decision regarding a patient with liver disease, the liver biopsy specimen has to be adequate and of high quality for pathological interpret...
What is the current status of trial NCT04751045?
This trial is currently completed. It is a NA study. The enrollment target is 78 participants. The study started on 2020-10-25. Estimated completion is 2021-10-01.
What interventions are being tested in trial NCT04751045?
The interventions under investigation include: EUS liver biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT04751045?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
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